InfluenzaPhase 3NCT02290509
Safety and Immunogenicity of Flublok Quadrivalent vs IIV4 in Adults 18-49 Years of Age
A Phase 3 study testing Flublok Quadrivalent and Inactivated Influenza Vaccine (IIV4) in people with Influenza, run by Protein Sciences Corporation at 10 sites in United States.
Trial summary
Randomized, double-blind trial of safety and immunogenicity of Flublok Quadrivalent versus Inactivated Influenza Vaccine (IIV4) in 1350 healthy, medically stable adults 18-49 years of age. Serum samples for Hemagglutinin Inhibition titers will be determined pre- and 28 days post-vaccination. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Flublok Quadrivalent and Inactivated Influenza Vaccine (IIV4)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,350 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2014to May 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ambulatory, in good health or medically stable
- Able to understand and comply with planned study procedures
- Provide written informed consent
- Negative urine pregnancy test within 24 hours prior to vaccination (women of child-bearing potential)
Who cannot join
- Prior serious or severe reaction to influenza vaccine
- Known contraindication to either study vaccine
- Receipt of any other influenza vaccine within 180 days prior to enrollment
- Plan to receive another licensed influenza or other vaccine during the duration of this study
- Receipt of any significant new diagnosis, medication (licensed or investigational), or licensed vaccine within 30 days prior to enrollment in this study
- Underlying disease or therapeutic intervention that might adversely affect the immune response
Show all 9Show fewer
- Plans to participate in any investigation involving an investigational product during this study.
- Pregnant, lactating or planning to become pregnant within 30 days of study vaccine.
- Any clinical or social circumstance that in the opinion of the investigator could interfere with compliance with study procedures or interfere with the interpretation
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Benchmark Reseach
Austin, Texas, 78705
Meridian Research
Bellevue, Nebraska, 68005
Clinical Research of South Florida
Coral Gables, Florida, 33134
Meridian Research
Dakota Dunes, South Dakota, 57049
Benchmark Research - Fort Worth
Fort Worth, Texas, 76135
Benchmark Research
Metairie, Louisiana, 70006
Meridian Clinical Research
Omaha, Nebraska, 68164
Benchmark Research - Sacramento
Sacramento, California, 95816
Meridian Clinical Research
Savannah, Georgia, 31406
Heartland Research Associates, LLC
Wichita, Kansas, 67207
About this study
Official title: Double-Blind, Randomized, Active-Controlled Comparison of the Immunogenicity and Safety of Flublok® Quadrivalent Versus IIV4 in Healthy, Medically Stable Adults 18-49 Years of Age
Randomized, double-blind trial of safety and immunogenicity of Flublok Quadrivalent versus Inactivated Influenza Vaccine (IIV4) in 1350 healthy, medically stable adults 18-49 years of age. Serum samples for Hemagglutinin Inhibition titers will be determined pre- and 28 days post-vaccination. Subjects will be followed for 6 months after vaccination for serious and/or medically-attended adverse events.
Read the detailed description
As the spectrum of influenza vaccines rapidly evolves to quadrivalent formulations with the intention of offering broader protection to include both lineages of influenza B strains, it is appropriate to transition Flublok from a trivalent to a quadrivalent formulation. The demonstration of non-inferior post-vaccination Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) to antigens in the Flublok Quadrivalent formulation compared to those of the matching antigens in a US - approved IIV4 is intended to support licensure of Flublok Quadrivalent for the adult population for which Flublok trivalent is currently approved. The comparison of safety and reactogenicity of Flublok Quadrivalent to that of IIV4 is expected to confirm a similar safety profile.
- Conditions
- Influenza
- Being tested
- Flublok Quadrivalent, Inactivated Influenza Vaccine (IIV4)
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flublok QuadrivalentBiological
Intramuscular injection of study vaccine
Inactivated Influenza Vaccine (IIV4)Biological
Intramuscular injection of study vaccine
| Study group | Role | What they receive |
|---|---|---|
| Flublok Quadrivalent Influenza Vaccine | Experimental | Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL Receives: Biological: Flublok Quadrivalent |
| Inactivated Influenza Vaccine (IIV4) | Active comparator | Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. Receives: Biological: Inactivated Influenza Vaccine (IIV4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
Seroconversion is defined as: Either a pre vaccination titer < 10 (1/dil) and a post vaccination titer ≥ 40 (1/dil), or a pre vaccination titer ≥ 10 (1/dil) and a ≥ 4 fold increase in post vaccination titer at Day 28 after the final vaccination.
Measured: Day 28 after final vaccination
Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
Immunogenicity will be evaluated prior to vaccination and at 28 days after vaccination using the hemagglutination inhibition (HAI) technique. For each influenza vaccine strain, pre and post vaccination geometric mean titers (GMTs) were calculated.
Measured: Day 0 and Day 28 after final vaccination
Secondary outcomes (2)
Number of Participants With Systemic and Injection Site Reactogenicity
Measured: Days 0-7
Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs)
Measured: Six months post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Protein Sciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health, Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- William Seger, MD, Principal investigator, Benchmark Research, Fort Worth, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290509
- Sponsor's protocol ID
- PSC16
- Status last verified
- Sep 2016
- First submitted
- 4 Nov 2014
- Last updated
- 27 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Dunkle LM, Izikson R, Patriarca PA, Goldenthal KL, Muse D, Cox MMJ. Randomized Comparison of Immunogenicity and Safety of Quadrivalent Recombinant Versus Inactivated Influenza Vaccine in Healthy Adults 18-49 Years of Age. J Infect Dis. 2017 Dec 5;216(10):1219-1226. doi: 10.1093/infdis/jix478.
PubMed 28968871
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Randomized, Active-Controlled Comparison of the Immunogenicity and Safety of Flublok® Quadrivalent Versus IIV4 in Healthy, Medically Stable Adults 18-49 Years of Age
- ClinicalTrials.gov ID
- NCT02290509
- Acronym / sponsor ID
- PSC16
- Conditions
- Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,350 participants (actual)
- Lead sponsor
- Protein Sciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health, Department of Health and Human Services
- Study start
- Oct 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 14 Nov 2014 (estimated)
- Results
- Posted 22 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, double-blind trial of safety and immunogenicity of Flublok Quadrivalent versus Inactivated Influenza Vaccine (IIV4) in 1350 healthy, medically stable adults 18-49 years of age. Serum samples for Hemagglutinin Inhibition titers will be determined pre- and 28 days post-vaccination. Subjects will be followed for 6 months after vaccination for serious and/or medically-attended adverse events.
Detailed description
As the spectrum of influenza vaccines rapidly evolves to quadrivalent formulations with the intention of offering broader protection to include both lineages of influenza B strains, it is appropriate to transition Flublok from a trivalent to a quadrivalent formulation. The demonstration of non-inferior post-vaccination Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) to antigens in the Flublok Quadrivalent formulation compared to those of the matching antigens in a US - approved IIV4 is intended to support licensure of Flublok Quadrivalent for the adult population for which Flublok trivalent is currently approved. The comparison of safety and reactogenicity of Flublok Quadrivalent to that of IIV4 is expected to confirm a similar safety profile.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flublok Quadrivalent Influenza Vaccine | Experimental | Biological: Flublok QuadrivalentIntramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL |
| Inactivated Influenza Vaccine (IIV4) | Active comparator | Biological: Inactivated Influenza Vaccine (IIV4)Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ambulatory, in good health or medically stable
- Able to understand and comply with planned study procedures
- Provide written informed consent
- Negative urine pregnancy test within 24 hours prior to vaccination (women of child-bearing potential)
Key exclusion criteria (9 listed)
- Prior serious or severe reaction to influenza vaccine
- Known contraindication to either study vaccine
- Receipt of any other influenza vaccine within 180 days prior to enrollment
- Plan to receive another licensed influenza or other vaccine during the duration of this study
- Receipt of any significant new diagnosis, medication (licensed or investigational), or licensed vaccine within 30 days prior to enrollment in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flublok QuadrivalentIntramuscular injection of study vaccine | Biological | Flublok Quadrivalent Influenza Vaccine |
| Inactivated Influenza Vaccine (IIV4)Intramuscular injection of study vaccine | Biological | Inactivated Influenza Vaccine (IIV4) |
Primary outcome
Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
Time frame: Day 28 after final vaccination
Seroconversion is defined as: Either a pre vaccination titer < 10 (1/dil) and a post vaccination titer ≥ 40 (1/dil), or a pre vaccination titer ≥ 10 (1/dil) and a ≥ 4 fold increase in post vaccination titer at Day 28 after the final vaccination.
Geometric Mean Titers of Antibodies to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine
Time frame: Day 0 and Day 28 after final vaccination
Immunogenicity will be evaluated prior to vaccination and at 28 days after vaccination using the hemagglutination inhibition (HAI) technique. For each influenza vaccine strain, pre and post vaccination geometric mean titers (GMTs) were calculated.
2 secondary outcomes
Number of Participants With Systemic and Injection Site Reactogenicity
Time frame: Days 0-7
Number of Participants With Serious Adverse Events (SAEs) and Medically-attended Adverse Events (MAEs)
Time frame: Six months post-vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28968871Dunkle LM, Izikson R, Patriarca PA, Goldenthal KL, Muse D, Cox MMJ. Randomized Comparison of Immunogenicity and Safety of Quadrivalent Recombinant Versus Inactivated Influenza Vaccine in Healthy Adults 18-49 Years of Age. J Infect Dis. 2017 Dec 5;216(10):1219-1226. doi: 10.1093/infdis/jix478.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Seger, MD principal investigator
Benchmark Research, Fort Worth, TX
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Flublok Quadrivalent and Inactivated Influenza Vaccine (IIV4) in people with Influenza, run by Protein Sciences Corporation at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion to Vaccine Antigens Following Vaccination With Quadrivalent Vaccine (time frame: Day 28 after final vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02290509, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.